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7.4.
Change Control
Change control involves tracking software and hardware versions used for specific data collection and
management activities so that data can be reproduced using the version used to create it (e.g., instrument
software versions) and so that if problems or “bugs” are identified in specific hardware or software
versions, the affected data can be identified and fixed. MERC tracks the hardware configuration and
software versions loaded on each PC during set-up.
The purpose of retesting and recalibration is to verify that a new system is compatible with the previous
system and that it will accommodate previous data entry and data reduction programs without impact to
formats and output are not changed. For more complex applications, a data set may be re-entered, tested,
or plotted and the outputs compared. In these cases, testing results should be documented in the project
files. The performance of hardware and software may require retesting if:
•
Hardware components are changed.
•
Software configuration is modified.
•
New or updated software is installed.
The Program Coordinator and Facility Manager must be aware of hardware and software change control
and potential impacts of version differences. They are responsible for determining if and how retesting is
required and how retesting will be accomplished and documented.
7.5.
Purchased Hardware and Software
Any specialized hardware or software purchased for a specific MERC application must be evaluated to
ensure that it meets the intended use requirements and that it complies with any contractual requirements
and standards. The evaluation process will be defined in the QAPP and/or documented in the project files.
7.6.
Validation Policy
Since nearly all hardware and software used for MERC is commercially available, wide public use and
continued market viability is considered proof of software dependability; therefore, validation is not
considered necessary. However, verification of data analysis techniques within each program is required.
For example, spreadsheet formulas and output shall be independently reviewed, verified, and
documented.
7.7.
Roles and Responsibilities
The Information Resources offices of the MERC Partner institutions have the primary responsibility for
setting policy and guidance for the management and development of computer-related program support
for MERC These offices are responsible for their respective institution’s Local Area Network, database
management, information security, personal computing and information access, application development,
desktop support, training, and records management.